Fluoroquinolone antibiotics are in a class of antibactierial drugs that are indicated for the treatment of a wide array of infections, including respiratory and urinary tract infections. The medications are broad-spectrum antibacterials that prevent bacterial cells from duplicating.
Fluoroquinolones include Avelox (moxifloxacin), Cipro (ciprofloxacin), Factive (gemifloxacin), Floxin (ofloxacin), Levaquin (levofloxacin), Noroxin (norflaxacin), Ocuflox (Ofloxacin), and Quixin (Levofloxacin). As of 2011, more than 23 million patients were prescribed a fluoroquinolone.
Fluoroquinolones also have the potential for QT prolongation and other significant side effects that should be considered when choosing an antibacterial drug and have long been linked to dangerous side effects such as increased risks of suffering acute kidney failure. Avelox and Levaquin have been linked to liver injury in the elderly and, in general, fluoroquinolone antibiotics are associated with severe tendon injuries, including tendon rupture and tendonitis.
Fluoroquinolone use has also been linked to detached retinal problems. Retinal detachment can lead to permanent blindness if not surgically treated within a few days of onset.
Federal health officials have issued a warning that they are updating the safety labels of antibacterial fluoroquinolone drugs to indicate serious side effects associated with the popular medications. Levaquin neuropathy and Levaquin peripheral neuropathy may be experienced by people taking this medication.
The U.S. Food and Drug Administration (FDA) announced that it is ordering the makers of these antibacterial fluoroquinolone drugs to update the medications’ safety labels to “better describe” the side effect of peripheral neuropathy. The FDA warning only deals with the oral and injectable forms of the drugs. These medications are also available in topical solutions that are applied to the ears and eyes; however, the risks of peripheral neuropathy in those applications are not present or do not necessitate a warning.
The FDA warns that patients who begin to develop signs of peripheral neuropathy should stop taking antibacterial fluoroquinolone drugs and switch to another form of antibacterial drug. Some signs of peripheral neuropathy, according to the agency’s warning statements, include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position.
These symptoms may occur at any time and people taking the drugs subject to the FDA’s warning should immediately notify their physicians to get started on another drug treatment.
FDA Updates Warning Label to Reflect Central Nervous System Side Effects
On July 26, 2016, the FDA announced new safety labeling changes for fluoroquinolones to reflect the risk of “disabling and potentially permanent side effects” affecting tendons, muscles, joints, nerves, and the central nervous system. The FDA indicated that, in patients with less serious bacterial infections, use of the antibiotics should be limited. The agency updated a Boxed Warning and made revisions to the “Warnings and Precautions” section of fluoroquinolone labels.
Approved fluoroquinolones include Levaquin (levofloxacin), Cipro (ciprofloxacin), ciprofloxacin extended-release tablets, Avelox (moxifloxacin), Floxin and Ocuflox (ofloxacin), and Factive (gemifloxacin). These drugs kill or inhibit bacterial growth, but an FDA safety review found that both oral and injectable fluoroquinolones were linked to “disabling side effects” that may affect the tendons, muscles, joints, nerves, and the central nervous system, the FDA said in its news release. The agency also wrote that the side effects may be permanent and may appear anywhere from hours to weeks after the antibiotics are used.
“Fluoroquinolones have risks and benefits that should be considered very carefully,” Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, wrote in the release. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”
According to the FDA, the risks associated with fluoroquinolone antibiotics generally outweigh the benefits in patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections. As such, the agency wrote, these drugs should only be used for these conditions if patients have no other options. This recommendation does not apply to some serious bacterial infections such as anthrax, plague, and bacterial pneumonia.
The link between permanent nerve damage and fluoroquinolones was first documented by a Belgian doctor in 1992. The FDA notified Bayer of numerous nerve damage reports in 2002.
The approved safety labeling changes are a follow-up to a May 12, 2016 drug safety communication indicating that the drugs should only be used in situations in which no other treatment options are available. In November 2015, an FDA Advisory Committee concluded that the risks of fluoroquinolones generally outweighed the benefits in patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections. The committee reviewed new safety information focusing on two or more side effects occurring simultaneously, leading to permanent health consequences.
Federal Regulators Warn that Fluroquinolone Antibacterial Drugs be Restricted for Certain
In May 2016, the FDA issued a warning that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients who have been diagnosed with sinusitis, bronchitis, and uncomplicated urinary tract infections (UTIs) who have other treatment options. For patients who have been diagnosed with any of these conditions, fluoroquinolones should be reserved for individuals who have no other alternative treatment options.
An FDA safety review has revealed that when fluoroquinolones are used systemically, such as in tablets, capsules, and injectable forms, the drugs are tied to disabling and potentially permanent serious side effects that may occur together and may involve the tendons, muscles, joints, nerves, and central nervous system. Because of this, the FDA is now mandating drug labels and “Medication Guides” for all fluoroquinolone antibacterial drugs be updated to reflect the new safety information.
The FDA issued a Drug Safety Communication in May 2016 that lists the currently available FDA approved fluoroquinolones for systemic use.
|Brand Name||Brand Name Active Ingredient|
|Cipro extended-release*||Ciprofloxacin extended-release+|
|+ available as generic * available only as generic|
What Is The Cause Of Peripheral Neuropathy?
The symptoms of peripheral neuropathy usually start rapidly and within just a few days of beginning a fluoroquinolone such as Levaquin. Nerve damage symptoms associated with peripheral neuropathy may last months and may become permanent, even if the drug is stopped.
Peripheral neuropathy has been a listed adverse reaction of fluoroquinolone drugs since 2004, with reports of long-lasting nerve damage and disability in people who take these medications.
Peripheral neuropathy involves damage to the nerves that transmit information to and from the brain, spinal cord, and body. Peripheral neuropathy damage interrupts the connection, creating varying symptoms depending on the nerves affected. Generally, symptoms are seen in the arms and legs and involve numbness, tingling, burning, or shooting pain.
Some of the available neuropathy treatments to relieve the symptoms of peripheral neuropathy include transcutaneous electrical nerve stimulation (TENS). During TENS, adhesive electrodes are placed on the skin while a gentle electric current is delivered through the electrodes and is dependent upon patient symptoms and history. Treatment is typically conducted daily for one month at 30 minutes per treatment.
Treatment for neuropathy may also include plasma exchange or immune globulin procedures. During diabetic neuropathy treatment that involves plasma exchange, the blood is removed from the body and a machine removes the immune cells prior to returning the blood. Another treatment for peripheral neuropathy involves immune globulin therapy in which high levels of proteins are administered and work as antibodies or immunoglobulins. Immunoglobulins help lower the immune system’s activity. Other treatments for neuropathy involve the use of hand or foot braces to support movement in the event of muscle weakness. Treatment of peripheral neuropathy may also involve physical therapy. Infrared therapy may be used to improve sensation.
FDA Labeling Updates
A prior FDA review revealed that the then-current warnings for fluoroquinolones were not adequate. The FDA’s recent alert mandates all drug labels and medication guides for fluoroquinolones be updated to better focus on the risk for serious and potentially irreversible peripheral neuropathy.
This is not the first serious warning issued by the agency for fluoroquinolones. In 2008, the FDA required a boxed warning, its most serious type of warning, be added to the drugs, advising patients of the risk of tendon damage, including rup ture.